BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE ILS CIRCULAR STAPLER

    MDR report key: 4092570 · Received September 16, 2014

    Report

    Report Number
    3005075853-2014-06439
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 27, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. AT THE TIME OF THIS SUBMISSION, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION REQUESTED: WHAT IS THE PATIENT¿S CURRENT CONDITION? WHAT CONFIRMATION DID THE SURGEON RECEIVE THAT THE ANVIL WAS FIRMLY ATTACHED? WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? WERE ANY UNEXPECTED NOISES HEARD? WHAT CONFIRMATION WAS RECEIVED INDICATING THE DEVICE WAS FULLY FIRED (SUCH AS CRUNCH, COMPRESSED UNTIL UNABLE TO FIRE FURTHER, ETC.)? DID THE WASHER GET CUT INTO TWO (2) PIECES? WERE THERE TWO COMPLETE TISSUE DONUTS? WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? WERE ANY UNFORMED OR MALFORMED STAPLES OBSERVED? HOW LONG HAS THE SURGEON BEEN USING THIS DEVICE FOR THIS PROCEDURE? WHO FIRED THE DEVICE? ASSISTANT OR THE SURGEON?

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: WHAT IS THE PATIENT¿S CURRENT CONDITION? PATIENT WENT HOME LAST THURSDAY (B)(6) 2014. WHAT CONFIRMATION DID THE SURGEON RECEIVE THAT THE ANVIL WAS FIRMLY ATTACHED? I WAS NOT IN THE CASES, WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? DO NOT KNOW, WERE ANY UNEXPECTED NOISES HEARD? NO. WHAT CONFIRMATION WAS RECEIVED INDICATING THE DEVICE WAS FULLY FIRED (SUCH AS CRUNCH, COMPRESSED UNTIL UNABLE TO FIRE FURTHER, ETC.)?I WAS NOT IN THE CASE, DID THE WASHER GET CUT INTO TWO (2) PIECES? NOT SURE. WERE THERE TWO COMPLETE TISSUE DONUTS? DO NOT KNOW. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? DO NOT KNOW. WERE ANY UNFORMED OR MALFORMED STAPLES OBSERVED? DO NOT KNOW. HOW LONG HAS THE SURGEON BEEN USING THIS DEVICE FOR THIS PROCEDURE? MANY YEARS. WHO FIRED THE DEVICE? ASSISTANT OR THE SURGEON? THE SURGEON.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SIGMOID PROCEDURE, THE SURGEON WAS USING THE DEVICE, FIRED THE DEVICE, AND WAS NOT SURE IF DEVICE FIRED STAPLES. THE SURGEON THEN ATTEMPTED TO REMOVE THE DEVICE BUT COULD NOT REMOVE IT FROM THE RECTUM. THE SURGEON CONVERTED TO OPEN PROCEDURE TO PUSH THE STAPLER OUT, AND WITH THE STAPLER WENT A LARGE AMOUNT OF MUCOSA. THE SURGEON RESECTED THE COLON AND HAD TO MOBILIZE AND LIGATE ALL THE WAY UP TO THE TRANSVERSE COLON. THE CASE WAS COMPLETED WITH ANOTHER DEVICE AND SUTURING. CURRENT PATIENT STATUS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573176 PROXIMATE ILS CIRCULAR STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention